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Factors Affecting Quality of Reprocessing FDA

The FDA has identified safety concerns in these three areasdevice design, reprocessing methods, and cleaning and disinfection and sterilization instructions.

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Disinfect your used N95 mask by 30 minute oven dry heat at 70 degrees Celsius or sterilize the face mask with the ultraviolet sterilization for 30 seconds. Please do not clean the respirator masks with steam air, hot water, alcohols, disinfectants, or detergents of any kind as they will damage the integrity and reduce the filtration efficiency

Reusable Medical Device Disinfection and Cleaning

Reusable medical devices come in all shapes and sizes, from specula to colonoscopes. Generally, these devices have expensive compo nents that require them to be cleaned and disinfected or sterilized. This article describes the salient points for validating that a medical device can be safely reused. It covers disinfection processes, not sterilization.

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Disinfect your used N95 mask by 30 minute oven dry heat at 70 degrees Celsius or sterilize the face mask with the ultraviolet sterilization for 30 seconds. Please do not clean the respirator masks with steam air, hot water, alcohols, disinfectants, or detergents of any kind as they will damage the integrity and reduce the filtration efficiency

Reusable Medical Device Disinfection and Cleaning

Reusable medical devices come in all shapes and sizes, from specula to colonoscopes. Generally, these devices have expensive compo nents that require them to be cleaned and disinfected or sterilized. This article describes the salient points for validating that a medical device can be safely reused. It covers disinfection processes, not sterilization.

FDA Requirements for Cleaning and Disinfection Validation

FDA's historical FDA requires all reusable medical devices to have cleaning and disinfection validation studies conducted, with the scope of the studies being proportional to the device's potential to serve as a vehicle for infectious disease. For the following devices, FDA must review and approve cleaning and validation data (typically

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